Cleared Special

K253924 - PuraStat (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253924 · 3-D Matrix Europe SAS · General & Plastic Surgery device
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Jan 2026
Decision
30d
Days
Class 2
Risk

K253924 is an FDA 510(k) clearance for the PuraStat. Classified as Hemostatic Device For Endoscopic Gastrointestinal Use (product code QAU), Class II - Special Controls.

Submitted by 3-D Matrix Europe SAS (Caluire Et Cuire, FR). The FDA issued a Cleared decision on January 7, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4456 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3-D Matrix Europe SAS devices

Submission Details

510(k) Number K253924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date January 07, 2026
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 114d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4456
Definition Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QAU Hemostatic Device For Endoscopic Gastrointestinal Use

All 9
Devices cleared under the same product code (QAU) and FDA review panel - the closest regulatory comparables to K253924.
Nexpowder
K240994 · Nextbiomedical Co., Ltd. · Nov 2024
PuraStat
K242250 · 3-D Matrix Europe SAS · Oct 2024
Resolv Endoscopic Hemostat System
K234131 · Hemostasis, LLC · Jul 2024
PuraStat
K222481 · 3-D Matrix, Inc. · Feb 2023
Nexpowder
K202929 · Nextbiomedical Co., Ltd. · Sep 2022
PuraStat-GI
K210098 · 3-D Matrix, Inc. · Jun 2021